Imiquimod versus PDT for actinic keratoses in in organ transplant recipients

Phase 1

• Conditions: actinic keratoses; MedDRA version: 14.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000263-24-AT
• Lead Sponsor: Medizinische Universität Wien, Univ. Klinik f. Dermatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-29
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Age 18 years or older
Patients who had received a kidney, liver, lung or heart transplant more than 3 years prior to inclusion into the study
Patients who had been treated at least 6 month prior to study entry with a stable twofold or threefold immunsupressive treatment
Patients who have clinically confirmed epithelial dysplasia (actinic keratoses), equally distributed in contralateral areas on the hands or forearms
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Invasive squamous cell carcinoma or basal cell carcinoma in the treatment area
Known allergy to imiquimod and aminolevulinic acid
Patients who have received retinoids, interferons or investigational drugs within 4 weeks of study initiation
Patients who are participating in other dermatological study
Patients with instable organ function
Persistent Hepatitis B or C infections
Any evidence of systemic cancer
Patients who have received any systemic cancer chemotherapy or radiation therapy
Pregnant and lactating women
Patients with other dermatological diseases (psoriasis, eczema) who might confound clinical outcome
Pateitns unable to sticjk with the study protocol
Severe compromised general state

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified